PepGen(US:PEPG)2025-11-12 13:00Financial Performance - PepGen reported net losses of $71.3 million and $67.7 million for the nine months ended September 30, 2025, and September 30, 2024, respectively [100]. - For the nine months ended September 30, 2025, the net cash used in operating activities was $65.8 million, compared to $62.9 million for the same period in 2024, reflecting a net loss of $71.3 million in 2025 versus $67.7 million in 2024 [138][139]. - Total operating expenses increased slightly by $0.5 million to $73.9 million compared to $73.4 million in 2024 [120]. - For the three months ended September 30, 2025, total operating expenses decreased by $4.5 million to $18.7 million from $23.2 million in the same period of 2024, primarily due to a reduction in research and development expenses [115]. Cash and Liquidity - As of September 30, 2025, PepGen had cash, cash equivalents, and marketable securities totaling $163.7 million, with an accumulated deficit of $342.8 million [100]. - The company expects its existing cash and marketable securities to fund operations into the second half of 2027, with no expected revenue from product sales until regulatory approval is obtained [101]. - As of September 30, 2025, the company had $163.7 million in cash, cash equivalents, and marketable securities, indicating a strong liquidity position [145]. - The company raised gross proceeds of $107.6 million from the sale of 31.25 million shares at $3.20 per share in the 2025 Offering [131]. Research and Development - Research and development expenses for the three months ended September 30, 2025, totaled $13.4 million, compared to $17.7 million for the same period in 2024 [106]. - The ongoing FREEDOM study for PGN-EDODM1 reported a mean splicing correction of 53.7% following a single 15 mg/kg dose, with all drug-related adverse events being mild or moderate [91]. - PepGen has decided to discontinue development of PGN-EDO51 and wind down all DMD-related research and development activities [94]. - Research and development expenses for the nine months ended September 30, 2025, were $57.2 million, a decrease of $0.3 million from $57.5 million in 2024, mainly due to a $3.9 million decrease in preclinical costs [122]. Operating Expenses - General and administrative expenses decreased by $0.2 million to $5.2 million for the three months ended September 30, 2025, primarily due to a reduction in personnel-related costs [117]. - General and administrative expenses increased by $0.8 million to $16.7 million for the nine months ended September 30, 2025, driven by increased consulting and legal expenses [123]. - Research and development expenses for the three months ended September 30, 2025, were $13.4 million, down from $17.7 million in 2024, reflecting a $1.4 million decrease in personnel-related costs and a $1.2 million decrease in manufacturing costs [116]. Financing Activities - Net cash provided by financing activities increased to $108.2 million for the nine months ended September 30, 2025, compared to $88.6 million in 2024, driven by proceeds from the 2025 Offering [142][143]. - The net cash provided by financing activities in 2025 included $108.1 million from the 2025 Offering, highlighting successful capital raising efforts [142]. Regulatory and Designation Updates - The FDA has granted orphan drug designation and Fast Track designation for PGN-EDODM1 for the treatment of DM1 [93]. - The company has filed a shelf registration statement covering the offering of up to $300 million in various securities, effective June 16, 2023 [127]. Other Financial Metrics - Interest income for the three months ended September 30, 2025, was $0.6 million, down from $1.8 million in the same period of 2024 [118]. - Non-cash adjustments in operating activities included $8.2 million of stock-based compensation and $1.1 million of depreciation expense for the nine months ended September 30, 2025 [138]. - The company experienced a decrease of $3.5 million in accrued expenses and a decrease of $2.3 million in operating lease liabilities during the nine months ended September 30, 2025 [138]. - The company reported a decrease in accrued expenses primarily due to lower research and development accruals, amounting to $5.8 million for the nine months ended September 30, 2024 [139]. - The company’s investments in marketable securities resulted in $58.0 million in maturities during the nine months ended September 30, 2025 [140]. - There were no material changes to the company's critical accounting policies and estimates from those described in the previous financial statements [144].